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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION NC EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7310
Device Problems Break (1069); Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/01/2021
Event Type  Injury  
Event Description
It was reported that a balloon detachment and unretrieved device fragment occurred. The target lesion was an in-stent restenosis located in a calcified vessel. A 4. 00mm x 6mm nc emerge balloon catheter was advanced for dilation. During the procedure, the balloon had deflation issues, became stuck and was difficult to remove. The device was pulled out; however, the shaft broke, and the balloon detached and remained in the vessel. The detached balloon was stented against the vessel wall. The procedure was delayed but was successfully completed. No further complications were reported.
 
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Brand NameNC EMERGE
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12805419
MDR Text Key280821199
Report Number2134265-2021-14207
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7310
Device Catalogue Number7310
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/12/2021 Patient Sequence Number: 1
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